Remote psychological evaluation

ABSTRACT

Instrumented orthoses with more sophisticated structures provide for coordinated support and rehabilitation of complex joints and multiple injured joints. Improved instrumented orthoses can include hinges that can rotate in multiple different planes. Particularly preferred embodiments include a shoulder brace with a hand hold and a lower extremities brace. Preferably, a control unit monitors the output Of transducers used to instrument the brace. A patient can be prompted by the control unit for the performance of a variety of different monitored exercises.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/997,737 filed on Nov. 24, 2004 now abandoned to Stark et al.,entitled “Remote Psychological Evaluation,” which is a continuation ofU.S. patent application Ser. No. 09/339,071 filed on Jun. 23, 1999 toStark et al., now U.S. Pat. No. 7,416,537, entitled “RehabilitativeOrthoses,” both of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

The invention relates to orthoses useful for the rehabilitation ofpatients with injured joints, weakened joints, and/or neurologicaldeficits degrading motor control or operation of joints. Moreparticularly, the invention relates to instrumented orthoses for theperformance of monitored rehabilitative exercises.

Both muscles and bones should be exercised to maintain strength. Also,bone fractures that are exposed to permissible weight bearing stressoften heal more predictably and more rapidly than fractures that are notstressed at all. Improved healing based on application of appropriatestress is also believed to be true for connective tissue, such asligaments and cartilage.

In the case of neurological injury or degradation, the nerve impulsepathways that control skeletal motor functions and joints areinterrupted due to loss of brain cells or nerve conducting structures.Such neurological injuries can result from cerebrovascular accidentssuch as ischemic or hemorrhagic strokes or certain types of head trauma.Recovery mechanisms involve creation of new neurological pathways byretraining the motor functions with different surviving brain cells asreceptors. This requires physical therapy and joint exercise verysimilar to exercise that is advantageous for rehabilitation of jointsfollowing orthopedic injury. Additionally, joint disuse following suchneurological injury similarly requires orthopedic rehabilitation andstress to effect useful recovery, given the secondary orthopedic damageresulting from the disuse.

Suitable stress can be applied to the tissue by the performance ofselected exercises. For example, isometric exercises generally involvesthe exertion of force against a relatively immovable object. To performisometric exercises, a restraining device can be used that has asubstantially unchanging position for the duration of a particularexercise routine. Isotonic exercises involve exertion against the sameweight or resistance through a range of motion. Isokinetic exercise isdesigned to mimic exertions that take place on a playing field or thelike. When performing isokinetic exercises in a simulated environment, amachine is used to provide resistance in direct proportion to theexertion of the exerciser.

Isometric exercises are particularly useful with painful injuries tolower the risk of further injury. If performed in a controlled manner,isometric exercises can be performed earlier in the recuperation periodto speed recovery. As the patient's recovery progresses, isotonicexercises or other exercises can be used to reestablish a desired rangeof motion about a joint. With continuing recovery, eventually thepatient is able to perform a full range of exercises.

A difficulty with the application of stress to an injured joint is thatthe application of excessive stress can further injure the joint ratherthan assist with the healing. Thus, the exercises need to be carefullyplanned to provide appropriate amounts of stress. Also, the performanceof the exercises should be monitored closely by a physician, physicaltherapist or other appropriate health care professional to optimize thetreatment and to reduce the risk of injury. The need to carefully planand closely monitor the exercises provides a cost and motivation barrierto accessing desirable amounts of exercise.

SUMMARY OF THE INVENTION

In a first aspect, the invention pertains to an instrumented orthosiscomprising:

-   a support that fits around the joint of a patient, the support    comprising a hinge that can rotate in different planes;-   a position sensor operably connected to the hinge such that motion    can be measured with respect to different rotational motions about    the joint; and-   a control unit operably connected to the position sensor to receive    signals related to the position of the hinge.

In another aspect, the invention pertains to method of rehabilitating ajoint that has a range of motion in a plurality of planes. The methodinvolves exercising with an orthosis having a hinge that can rotate indifferent planes. The hinge preferably includes a position sensor thatcan provide measurement of the orientation of the hinge in the differentplanes. The orthosis includes a control unit connected to one or moreposition sensors.

In a further aspect, the invention pertains to an orthosis comprising:

-   a support that fits around a plurality of joints of a patient, the    support comprising a plurality of hinges such that motions about    separate hinges correspond to motions about different joints;-   position sensors operably connected with the hinges such that motion    can be measured about different joints; and-   control unit operably connected to the position sensors to receive    signals related to the position of the hinges.

Moreover, the invention pertains to a method of upper bodyrehabilitation comprising exercising two or more adjacent joints usingan ambulatory orthosis supporting the two or more adjacent joints. Theorthosis preferably is connected to a control unit that provides atarget exercise routine and immediate feedback on patient performancerelative to the target exercise routine with respect to motion abouteither of the adjacent joints.

In additional aspects, the invention pertains to a leg orthosisincluding:

-   an ambulatory support structure including:-   a waist support;    -   an upper leg support;    -   a lower leg support;-   a hinge connecting the waist support with the upper leg support;-   a hinge connecting the upper leg support and the lower leg support;-   sensors operably connected to the support structure to measure    forces applied to the support structure; and-   a control unit connected to the sensors to receive measurements    related to the applied forces.

In another aspect, the invention pertains to a method of rehabilitatinga stroke victim including performing a set of exercises using anambulatory orthosis supporting the hip and knee. The orthosis preferablyis connected to a control unit that provides a target exercise routinedirecting the application of forces by the patient at the hip and kneeand provides immediate feedback on patient performance relative to thetarget routine.

In a further aspect, the invention pertains to a shoulder orthosisincluding:

-   -   an ambulatory shoulder support;

-   a hand hold extending from the shoulder support;

-   a transducer operably connected to the hand hold such that forces    applied to the hand hold result in an altered signal from the    transducer; and

-   a control unit connected to the transducer to receive measurements    of forces applied to the hand hold.    The ambulatory shoulder support preferably includes a trunk support    and an under arm support directly or indirectly connected to the    trunk support by a hinge, preferably a multi-dimensional hinge.

In addition, the invention pertains to a method of evaluating apatient's mental condition comprising:

-   collecting answers to a set of questions regarding the patient's    mental condition using a remote controller programmed to pose the    questions and receive the answers; and-   evaluation of the answers by a health care professional.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic perspective view of an orthosis for supporting twojoints.

FIG. 2 is a schematic perspective view of an orthosis with a hingecapable of rotating in multiple planes.

FIG. 3 is a schematic perspective view of an embodiment of a supportportion.

FIG. 4 is a schematic perspective view of an alternative embodiment of asupport portion.

FIG. 5 is a sectional top view of a hinge with a mechanical lockingfeature and a position sensor, where the section is taken through thecentral axis of the hinge.

FIG. 6 is a side view of a portion of the hinge of FIG. 5 with anotherportion removed.

FIG. 7 is a top view of an electromechanical hinge, where a portion ofthe casing and other structures are removed to expose internalstructure.

FIG. 8 is a sectional, side view of the electromechanical hinge of FIG.7 taken along line 8-8.

FIG. 9 is an exploded, perspective view of an embodiment of a mechanicalhinge with an easy to use locking mechanism.

FIG. 10 is a sectional front view of a manual resistance unit that canbe used with the mechanical hinge of FIG. 9.

FIG. 11 is a side view of an orthosis with an articulating hingeconnecting two support portions.

FIG. 12 is a side view of a mechanical, biaxial hinge.

FIG. 13 is a fragmentary, perspective view of one embodiment of a hingethat provides for motion in two planes.

FIG. 14 is an exploded, perspective view of the principle components ofthe hinge of FIG. 13.

FIG. 15 is a fragmentary, perspective view of an alternative embodimentof a hinge that provides for rotation in two planes.

FIG. 16 is a fragmentary, perspective view of an orthosis with a squeezeball for the patient's hand.

FIG. 17 is a fragmentary, perspective view of an orthosis with a squeezeball of FIG. 16 and a wrist hinge.

FIG. 18 is a fragmentary, perspective view of an orthosis with a handgrip.

FIG. 19 is a front view of a shoulder orthosis.

FIG. 20 is a perspective, front view of a lower extremity orthosis.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Sophisticated instrumented orthoses/braces provide for more complex andcoordinated rehabilitation exercises than previously possible. Inparticular, certain embodiments are suitable for the rehabilitation ofcomplex joints that enable motion in multiple, different planes. Thesecomplex joints can be rehabilitated much more efficiently andappropriately using the more sophisticated orthoses described herein.Furthermore, other embodiments of the improved orthoses are particularlysuitable for the rehabilitation of stroke victims. These stroke bracesprovide suitable rehabilitation for patients that have lost motorfunction on one side or both sides of their body. Thus, therehabilitation can involve muscle building as well as neuro-reflexretraining. Using these sophisticated orthoses, many seriousinjuries/illnesses can be treated more effectively than was possiblepreviously and, potentially, at a lower cost.

Certain embodiments of the improved orthoses are suitable for therehabilitation of joints that move in multiple planes of motion. Jointsthat move in multiple planes of motion include, for example, shoulder,spine, hip, wrist and ankle/foot. These orthoses include a supportstructure that fits around the joint and supports the body portionsconnecting at the joint. The support structure includes one or morehinges that provide for motion of the joint in multiple planes ofmotion. Position sensors preferably provide for measurements of theposition of the hinge in the multiple planes of motion. The hinge orhinges preferably provide for the measurement of the motion about two ormore planes of motion. The orthoses can include additional types oftransducers, such as strain gauges. Preferred embodiments includeinstrumented shoulder braces that provide for the multiple planes ofmotion of the shoulder. Preferred shoulder braces can further includeinstrumented supports for the arm, elbow and/or hand.

Certain embodiments of the improved orthoses are particularly suitablefor use as a stroke brace. Stroke victims can lose a significant portionof their motor control on one or both sides of their body. These victimsneed a particularly high level of support and can benefit tremendouslyfrom appropriate type of rehabilitative exercises. Because strokevictims generally have injuries that involve multiple joints, a strokebrace includes a support structure that provides support for multiplejoints. Preferred stroke orthoses include an upper extremity brace alongwith a long leg brace, although other embodiments can be used. Inpreferred embodiments, the support structures include hinges providingfor motion of multiple joints.

The hinges preferably include position sensors for measuring the motionabout the hinge. The orthoses can include additional types oftransducers, such as strain gauges. The orthosis can provide formultiple planes motion about one or more of the joints. Theinstrumentation of the orthosis generally involves a control unit thatis operably connected to transducers on the orthosis. The control unitcan be used to provide feedback and instructions to the patient toassist with the retraining of neurological pathways. Instrumentation ofthe orthosis reduces the need for professional intervention.

Hand injuries may not be adequately treated by standard types oforthoses with hinges. Furthermore, hand muscles can atrophy due toinactivity following an arm injury. An improved hand orthosis includesan instrumented squeeze device, such as an air-bulb or a foam grip.Generally, the instrumented squeeze ball is supported by a support thatextends, at least, to the patient's wrist. In certain embodiments, theinstrumentation measures the total force exerted by the hand onto thesqueeze ball. In other embodiment, the instrumentation provides formeasurements of forces applied by individual fingers. The capability tomeasure the force exerted by individual fingers is particularly suitablefor a stroke brace where redevelopment of neuromuscular control of themovement of individual fingers is a significant consideration.

As noted above, preferred embodiments of the improved orthoses include acontrol unit operably connected to transducers placed on the orthosisfor position, strain or other measurements. The control unit preferablyincludes a microprocessor to assist with the monitoring of therehabilitative exercises. Information regarding the compliance andperformance of the patient can be downloaded from the control unit forevaluation by a health care professional. Microprocessor based controlunits can provide instruction to and prompting of the patient for theperformance of the selected exercises. The selection of suitableexercises preferably is performed by a health care professionalfollowing an examination of the condition of the patient. The controlunit is programmed accordingly.

1. Orthosis Structure

Previous instrumented orthoses are designed for placement around asingle joint. Support portions support the respective body portions thatmeet at the joint. A selectively flexible connection/hinge connects thesupport portions at or near the joint such that rotation of the hingeprovides for motion around the joint. Hinges used in these orthosesprovide for rotation in a single plane. Transducers can provide formeasurements of strain within the support and/or the position of thehinge. A microprocessor based control unit provides for monitoring ofthe measurements of the transducers. To the extent that previousinstrumented orthoses have extended to multiple joints such as a kneebrace extending to the foot, the measurements at the second joint havenot involved rotation of the second joint. In other words, a forcedetector at the foot measures the force applied against the leg as awhole and not the force due to torque at the ankle. Further descriptionof previous instrumented orthoses is found in U.S. Pat. No. 5,484,389 toStark et al, entitled “Instrumented Orthopedic Restraining Device andMethod of Use,” incorporated herein by reference.

Various features of instrumented rehabilitation orthoses have beenrefined generally to provide for improved performance of the orthosis.Many of these features can be adapted for use in the improved orthosesdescribed herein. These features are described in detail in copendingand commonly assigned U.S. Provisional Application Ser. No. 60/098,779to Stark et al., entitled “ORTHOSES FOR JOINT REHABILITATION,”incorporated herein by reference, hereinafter “application No.60/098,779”. Certain of these features are described with particularitybelow, as appropriate. While application No. 60/098,779 is incorporatedherein in its entirety, it is referred to for particular features inadditional citations below.

Improved orthoses described herein provide for more sophisticatedrehabilitation procedures than previous instrumented orthoses. Referringto FIG. 1, certain embodiments of an improved orthosis 100 include afirst support portion 102, a second support portion 104, and a thirdsupport portion 106 such that multiple joints can be supported byorthosis 100. First support portion 102 preferably is connected tosecond support portion 104 by flexible connection/hinge 108. Similarly,second support portion 104 preferably is connected to third supportportion 106 by flexible connection/hinge 110. Control unit/controller112 can be connected to position sensors, described further below withinhinges 108 and 110 and to strain gauges 114, 116. Alternativeembodiments can include only one hinge or more than two hinges, with acorrespondingly appropriate number of support portions.

Support portions 102, 104, 106 can be connected directly to hinges 108,110 or by way of linkers 118, 120, 122, 124. In particular, linker 118links support portion 102 with hinge 108, linker 120 links supportportion 104 with hinge 108, linker 122 links support portion 104 withhinge 110 and linker 124 links support portion 106 with hinge 110.Linkers 118, 120, 122, 124 can have any desired rigid structure that issuitable given the structure of the support portion and the hinge.

Other embodiments 130 of the improved orthoses include hinges thatprovide for the motion of a joint in multiple planes. Referring to FIG.2, first support portion 132 and second support portion 134 areconnected to multidimensional hinge 136. As described further below,multidimensional hinge 136 can include a plurality of single planehinges or more complex structures. Support portions 132, 134 can bedirectly attached to multidimensional hinge 136 or by way of linkers138, 140, respectively. Orthosis 130 preferably includes, at least, onestrain gauge 142 to measure forces applied at hinge 136.

A variety of constructions can be used for the support portions 102,104, 106, 132, 134 (FIGS. 1 and 2) such that a support portion properlysupports the respective body portion. Referring to FIG. 3, a firstembodiment 150 of a support portion has frame members 152 and 154 thatextend on either side of a body portion. Straps 156 extend from oneframe member 152, 154 to the other to hold support portion 150 in placearound the corresponding body portion. Straps 156 can be replaced withfabric sheets or other flexible or rigid connectors. Straps 156 can besecured to frame members 152, 154 with any of a variety of fasteners,such as snaps, buckles, clamps and hook and loop fasteners. The lengthof straps 156 can be adjusted using conventional designs. A rope andpulley system can be used for tightening and loosening support structure150, as described further in application No. 60/098,779. Frame members152, 154 connect directly to hinge elements 158, 160, although linkerscan be used, if desired.

Referring to FIG. 4, an alternative embodiment 166 of a supportstructure that surrounds the corresponding body portion. Support portion166 generally is somewhat rigid and can be constructed from a variety ofmaterials. Preferred materials for the construction of support portion166 include, for example, molded plastic shells, plaster,water-activated fiberglass, heat moldable thermoplastics, heat shrinkplastic, and other cast forming materials. Support portion 166 can bepremolded in various sizes such that a particular size is selected“off-the-shelf” based on measurements of the patient. Alternatively,support portion 166 can be constructed to provide a custom fit for aparticular patient. These custom molded support portions are molded tofit the body portions of the particular patient by a trained physicianor technician.

Whether or not a linker is used to connect a particular support portionand a hinge, a hinge can involve just one or a plurality of distincthinge elements, as appropriate. As used herein, a hinge element is aphysically distinct structure that has two or more lever arms thatrotate relative to each other. A hinge includes one hinge element if asupport portion has a single lever arm connecting it by way of the hingeto the other support portion and more than one hinge element if asupport portion has multiple lever arms at distinct locations ofattachment to the support portion.

For example, as shown in FIG. 2, hinge 136 has a single hinge element,which corresponds to the hinge itself. In contrast, in FIG. 3 the hingeincludes two hinge elements 158, 160. Similarly, in FIG. 1 each hinge108, 110 is depicted with two hinge elements. More than two hingeelements can be included in a single hinge, although it is preferably touse one or two hinge elements per hinge. Support structure 166 in FIG. 4can be attached to one hinge element or two hinge elements by directattachment or using appropriate linkers. The hinge elements are placedsuch that the joint can rotate when the orthosis is properly placedaround the joint and the hinge elements are not in a locked position.

When forces are applied by the patient against the orthosis, theorthosis tends to change position relative to the patient's joint. Thisshifting reduces the effectiveness of any exercises being performed withthe orthosis and may necessitate realignment of the orthosis for properfit. The orthosis can be designed to reduce or eliminate this shifting.

A first approach to prevent a knee orthosis from slipping duringexercise is to construct the orthosis with indentations in the femursupracondylar area just above the knee. An alternative solution involvesthe use of additional securing cuffs. Securing cuffs are designed to betightened more during exercise routines to help secure the orthosisrelative to the joint. Securing cuffs include a gripping element and,for example, can be placed against the leg above the knee such that whentightened, the gripping element applies pressure above the kneecap andpushes on the knee without pushing on the vasculature and lymphaticdrainage posteriorly. In other embodiments, the securing cuffs can beappropriately placed. Cuffs 270, 272 can be tightened with a variety offasteners including hook and loop fasteners.

Another approach to securing the orthosis involves securing the orthosisto a belt by way of one or more straps. Still another approach involvesreducing the friction of the surface contacting the orthosis or part ofthe orthosis, for example, using a high friction, polymer sleeve. Stillanother approach to securing the orthosis involves the placement ofcrossed straps behind the joint. The straps apply forces that tend tomaintain the straps in the fold of the joint. Furthermore, for a kneeorthosis, the orthosis can end with a heel cup or other support placedalong the bottom of the foot. Such a foot support preferably includes astrap or the like around the foot to hold the bottom of the orthosis atthe bottom of the foot and, thus, to fix the hinge roughly at the knee.

With any of these approaches for inhibiting orthosis motion during use,the method preferably distributes the restraining forces sufficientlysuch that no portion of the skin is subject to excessive pressures thatcould bruise the skin as well as damage or interfere with neural orcirculatory functions. Most of these approaches for preventing movementof the support portions are described further in the application No.60/098,779.

Hinges 108, 110, 136 (FIGS. 1 and 2) are intended to be interpretedbroadly as any flexible connection that provides for angular motion ofone support portion relative to another support portion. Hinges 108,110, 136 preferably can be locked at a selected angle to protect thejoint from undesired motion and/or to provide for isometric exercises.Hinges 108, 110 can be mechanical, electromechanical or a combinationthereof, as described further below. In preferred embodiments, thehinge/flexible connection includes a position sensor such that therelative orientation of the hinge can be measured and monitored by thecontroller 112. For example, U.S. Pat. No. 5,052,375, to Stark et al.entitled “Instrumented Orthopedic Restraining Device and Method of Use,”incorporated herein by reference, discloses the use of apotentiometer-like mechanism used as a position sensor. Other suitableposition sensors can be used, such as magnetic or optical sensors thatare either digital or analog devices. Position sensing is useful for theevaluation of range-of-motion exercises and a variety of otherexercises, as described further in the application No. 60/098,779.

An embodiment of a suitable mechanical hinge capable of locking andunlocking is shown in FIG. 5. Hinge 180 includes a first engaging member182 and a second engaging member 184. Members 182, 184 have teeth 186,188, respectively, that engage when hinge 180 is in a locked position.Knob 190 is used to rotate bolt 192. Second engaging member 184 includesa threaded screw hole 194 that is mated with bolt 192 such that rotationof knob 190 moves knob 190 relative to member 184. Spring 196 tends toseparate members 182, 184 from each other to the extent allowed by therelative position of bolt 192 within threaded hole 194. Clip 198 withinrecess 200 prevents separation of bolt 192 from member 184. Referring toFIG. 6, strain gauges 202 are located on frame 204. Frame 204 can be alinker between hinge 180 and a support portion or a component of asupport portion.

Referring to FIGS. 5 and 6, hinge 180 includes a position sensing devicein the form of a variable resister. In particular, member 184 includestwo flexible wiper arms 210, 212. Wiper arms 210, 212 are in electricalcontact with each other such that current can flow between them.Flexible wiper arm 210 contacts resistance element 214, while flexiblewiper arm 212 contacts conducting element 216. Resistance element 214and conducting element 216 have an electrical potential differencebetween them. Resistance element 214 has an electrical connection 218 atone end such that the electrical resistance resulting from current flowthrough resistance element 214 depends on the position of wiper arm 212as determined by the relative angular orientation of member 184 relativeto member 182. Wires 220 provide for electrical connection of resistanceelement 214 and conducting element 216 directly or indirectly tocontroller 112.

Referring to FIG. 7, an electromechanical hinge 240 is shown. Hinge 240includes a first element 242, which connects to a first support portion244, and a second element 246, which connect to a second support portion248. Second element 246 connects with axle 250, which rotates withinshaft 252 such that second element 246 can rotate relative to firstelement 242. Axle 250 is secured with nut 254. Shaft 252 passes througharmature 256. Armature 256 is held within case 258. Case 258 is securedto first element 242.

Lead 270 electrically connects stator coil 272 within stator housing 274with a current source. Stator coil 272 is designed to attract armature256 when sufficient magnetic field is generated by electric currentflowing through stator coil 272. The current can be supplied fromcontroller 112. When armature 256 is attracted to stator coil 272, apair of free riding discs 276, 278 are gripped between armature 256 andstator housing 274. Outer disc 276 is made preferably from a suitablemetal, and inner disc 278 is made preferably from a suitable polymericmaterial to provide for a smooth grip between the surfaces and toprevent wear between the surfaces. A spring 280 biases armature 256 awayfrom stator housing 274 when the magnetic attraction between coil 272and armature 256 is insufficient to overcome the forces of spring 280.Sufficient attraction between coil 272 and armature 256 locks firstelement 242 relative to second element 246.

In preferred embodiments, a hinge provides selectable resistance torotation for the performance of isotonic exercises. For example in theembodiment of FIG. 7, lesser amounts of attraction between coil 272 andarmature 256 can result in selectable amounts of resistance/friction inthe rotation of first element 242 relative to second element 246. Theselectable resistance can be adjusted with controller 102 by varying thecurrent supplied by controller 102 to stator coil 272.

Referring to FIGS. 7 and 8, a position sensor/variable resistor includesa resistance element 290 and wirer arm 292. Resistance element 290 isconnected to case 258. Wiper arm 292 is keyed to rotate with axle 250such that rotation of second element 246 relative to first element 242rotates wiper arm 292 to different angular positions along resistanceelement 290. Conductor arm 294 provides current to wiper arm 292.Conductor arm is electrically insulated relative to case 258 whileproviding electrical connection by way of connection 296. Resistanceelement 290 is connected to electrical connection 298. Resistancemeasurements can be made by way of connectors 296, 298. Resistancemeasurements are a function of the angular position of support portion244 relative to second support portion 248.

Mechanical and electromechanical hinges are described further in U.S.Pat. No. 5,484,389 to Stark et al., incorporated herein by reference. Inparticular, a suitable electromechanical hinge with variable resistancecontrollable by way of controller 112 is described further in publishedPCT application WO 96/36278, entitled “An Orthopedic Device SupportingTwo or More Treatment Systems and Associated Methods,” incorporatedherein by reference.

A preferred embodiment of a left, mechanical hinge 300 is shown in FIG.9. This hinge has a construction that provides for particularly easyrelease of the lock by a patient with one hand. The orientation of thehinge is measured by a position sensor to assist the patient inresetting the lock at a desired orientation. A right hinge would be theminor image of the hinge in FIG. 9.

Hinge 300 includes a outer plate 302, washer 304, locking unit 306, ringlever 308, electrical resistance disc 310 and inner plate 312. Outerplate 302 is connected to a frame member 318. Strain gauge 319 can beattached to frame member 318. Outer plate 302 and inner plate 312include concentric stop holes 320, bolt holes 322, connection holes 324and slot 326. The corresponding holes are aligned between left outerplate 302 and inner plate 312.

One or two stop pins can be placed through two aligned stop holes 320 inouter plate 302 and inner plate 312 to define limits of hinge rotation.Bolts or other fasteners are secured through bolt holes 322 to holdhinge 300 together. Electrical resistance disc 310 rests within a hollow338 within inner plate 312. Electrical resistance disc 310 makeselectrical contact with wire 340.

Locking unit 306 includes control disc 346, slider 348, slider spring350 and lock-out latch 352. Control disc 346 includes bolt holes 322 anda slit 354 in which slider 348 slides. Slider 348 has a groove 356 andan indentation 358 with a catch 360. Lock-out latch 352 has a knob 362and a bar 364. Bar 364 slides within slots 326 and can fit within groove356 to hold slider 348 in a depressed, unlocked, position.

Ring lever 308 is connected with a frame member 370. Ring lever 308 hasan opening 372 with a diameter slightly larger than the diameter ofcontrol disc 346 such that control disc 346 can fit within opening 372.Control disc 346 preferably has a thickness slightly larger than ringlever 308. A set of concentric, notches 374 are located around the edgeof opening 372 of ring lever 308. Catch 360 of slider 348 fits withinthe notches 374 to lock the hinge at a particular orientation whenslider 348 is in an extended position. Depressing slider 348 against theforce of spring 350 disengages catch 360 from one of the notches 374such that hinge 300 is free to rotate within the bounds establishes byany stop pins. Ring lever 308 includes an electrical contact 376 setwithin a hole 378 that contacts electrical resistance disc 310.Electrical contact 476 is connected by wire 380 to controller 112 oralternative resistance meter.

Outer plate 302, inner plate 312, ring lever 308, control ring 346,lock-out latch 352 and slider 348 preferably are made from rigid,durable materials. In particular, outer plate 302 and inner plate 312are preferably made from an aluminum alloy, and ring lever 308, controlring 346, lock-out slide 352 and slider 348 preferably are made fromstainless steel. Spring 350 generally would be made from resilient steelor the like. Washer 304 and stop pin 330 generally are made frompolytetrafluoroethylene or the like. Electrical resistance disc 310 canbe made from circuit board material with a resistance elementscreen-printed on its surface.

Frame members 318 and 370 extend from hinge 300 such that movement offrame member 318 relative to frame member 370 involves rotation of hinge300. When hinge 300 rotates, outer ring 302 and inner ring 312 rotaterelative to ring lever 308. Outer ring 302, inner ring 312 and controldisc 346 are held fixed with respect to each other by way of boltspassing through bolt holes 322. The orientation of hinge 300 is lockedunless slider 348 is depressed such that catch 360 is withdrawn fromnotches 372. Lock-out slide 352 can hold slider 348 in the depressed,unlocked position. The position of ring lever 308 relative to inner ring312 can be measured by way of the position of electrical contact 376along electrical resistance disc 310. The relative position ofelectrical contact 376 along electrical resistance disc 310 provides avariable electrical resistance useful for position/orientation sensing.

It may be convenient to provide for release of a hinge with a remotecontrol. The release of an electromechanical hinge using a command fromthe controller is described above. It may be desirable to have a simplemechanical remote release. A simple photographic shutter release can beadapted for this purpose with the hinge of FIG. 9. The shutter releasecan be screwed at its threaded tip into hinge 300 at threaded hole 394in control ring 346. Pressing the plunger of the cable release advancesa cable, which in turn depresses slider 348 thereby unlocking hinge 300.Alternative designs for mounting of a manual hinge release involvepulling a plunger that in turn pulls slider 348 such that the lock isdisengaged and such that releasing the plunger reestablishes the hingelock.

While electronic control of the resistance in a flexibleconnection/hinge has advantages, cost and design simplicity favors apurely mechanical hinge Referring to FIG. 10, With a purely mechanicalhinge, such as shown in FIG. 5, strain gauge readings can be accuratelycalibrated to reflect the forces applied to move the hinge against asetting on a mechanical resistance applicator. Thus, control unit 112can be used to monitor the isotonic exercises even though the resistanceis not electronically controlled. A mechanical resistance applicator canbe made integral with the hinge, but in preferred embodiments theresistance unit can be separated from the hinge such that no resistanceis applied to the hinge when resistance is not desired. A resistanceapplicator can designed to amplify small changes in the resistance thatcorrelate with easily made changes in the position of a knob.

Referring to FIG. 10, a cross section through. the center of anembodiment of resistance applicator 400 is shown. Resistance applicator400 includes housing 404, a crank 406, a compression structure 408, knob410, bearing unit 412, washer 414 and spacers 416.

Housing 404 includes lock pins 428. A second lock pin is not shown inthe sectional drawing. Lock pins 328 provide releasable connection forattachment of resistance applicator 400 to a hinge, such as hinge 300 ofFIG. 9. In particular, lock pins 428 of resistance applicator 400 can besecured through connection holes 324 to releasably secure resistanceapplicator 400 in an operable position with respect to hinge 300.Alternative locking approaches can be used for the attachment of thefriction applicator to the hinge. Housing 404 includes threaded hole 432for engaging knob 410. Housing 404 further includes cylindricalprotrusion 438 for engaging compression structure 408.

Crank 406 includes cylindrical extension 454 for engaging compressionstructure 408 and pads 458, which engage a support portion, such thatrotation of the hinge of the orthosis rotates crank 406 relative tohousing 404.

Compression structure 408 provides for small changes in the resistancedue to changes in the distance between washer 414 and housing 404 asknob 410 is rotated, thus amplifying resistance changes by way of theknob. Compression structure 408 generally produces friction as a resultof shear forces within compression structure 408 due to relative motionof housing 404 and crank 406. In one embodiment, compression structure408 includes alternating crank discs and housing discs to form amultiple clutch plate. Crank discs engage crank 406, such that the crankdiscs rotate with crank 406. Housing discs have a central hole shaped toengage protrusion 438 in housing 404, such that housing discs rotatewith housing 404.

Knob 310 includes a threaded shaft 482 with threads and diametersuitable for engaging the threads of threaded hole 432 in housing 404.Bearing unit 412 preferably includes a ring of ball bearings in abearing case. Bearing unit 412 can be replaced with other bearingstructures or other friction reducing approaches such as hydro bearings.

Washer 414 has a suitable inner diameter such that threaded shaft 482can pass through the inner diameter but bearing unit 412 cannot pass.Washer 414 has an outer diameter such that washer 414 rests on extension454 of crank 406 covering the opening to compression unit 408 betweenhousing 404 and crank 406. Two optional spacers preferably are locatedwith one on each side of compression unit 408. The spacers have theshape of a washer but with a suitably larger inner diameter and smallerouter diameter than washer 414 such that the spacers fit within thecavity between crank 406 and housing 404.

The primary components of the resistance applicator 400 preferably aremade from metals and/or alloys. Aluminum alloys and stainless steel aresuitable metals for the construction of housing and crank components.Rigid polymers can be used in place of metals for the housing and crankelements. The spacers preferably are made of brass. The housing discpreferably is made from spring steel, and the crank disc preferably ismade from spring tempered phosphor bronze. The bearing case can be madefrom Nylon®.

Resistance applicator 400 is designed to attach to a hinge such thathousing 404 moves with a frame member attached to one side of the hingewhile crank 406 moves with a frame member attached to the other side ofthe hinge. Thus, rotation of the hinge results in rotation of housing404 relative to crank 406. Tightening of knob 410 presses washer 414down onto compression unit 408. Housing rings and crank rings rotaterelative to each other when housing 404 moves relative to crank 406.Increasing the pressure on compression unit 408 results in increasedresistance in the rotation of housing 404 relative to crank 406 becauseof friction between housing rings and crank rings. This design providesfor sensitive adjustment rotational resistance by rotation of knob 410.The improved hinge 300 shown in FIG. 9 combined with the improvedresistance applicator 400 is described further in the application No.60/098,779.

In alternative embodiments, a hinge takes the form of an articulatinghinge 490, as shown in FIG. 11. Articulating hinge 490 can be made withresilient collapsible materials such as a bendable straw, slidingsections that can slide past each other to articulate, or other similarconstructions. Sliding sections can be locked relative to one another byway of clamps 492 attached to slots 494 defining a range of motion,where the clamps are tightened manually with wing nuts or the like, orelectronically with solenoids or the like. As shown in FIG. 11,articulating hinge 490 is connected to two support portions 166 thatsurround the corresponding body portions. Alternatively, one or bothsupport portions 166 can be replaced with other types of supportportions or by linkers that connect the support portions to hinge 490.

Certain joints such as the knee are cams that do not involve rotationabout a single axis. A biaxial hinge can be used to more closelyapproximate the motion of the joint cam. A biaxial hinge 500generalizing on the structure of hinge 300 is shown in FIG. 11. Biaxialhinge 500 includes a proximal arm 502 and a distal arm 504. Proximal arm502 includes teeth, which engage teeth on distal arm 504. Proximal arm502 further includes lock notches and an electrical contact for position(orientation) sensing. A control ring operates similarly to control ring346 in hinge 300 to control the locking/unlocking of the hinge. Furtherdetails on biaxial hinge 500 can be found in the application No.60/098,779.

Orthosis 130 shown in FIG. 2 includes hinge 136 capable of rotation inmultiple planes to provide for multiple ranges of motion about a singlejoint. A first embodiment of a hinge capable of motion in multipleplanes is shown in FIG. 13 and an exploded view in FIG. 14. Hinge 510includes rod 512 that moves within sleeve 514. Sleeve 514 has fourresilient sections 516 that form a truncated conical shape. Sleeve 514further has threads 518. Cap 520 fits over and screws onto sleeve 514.Cap 520 includes worm gear threads 522. Lever 524 has mated worm gearthreads 526 to complete the worm gear with lever 524 adjacent cap 520.

Cap 520 can be screwed to varying degrees to increase or decrease thetension at resilient sections 516. Tension at resilient sections 516grips rod 512 to a corresponding degree. The worm gear comprisingthreads 522 and 526 can be used to screw cap 520 on to or off fromsleeve 514. The worm gear is advanced by the rotation of lever 524.

Hinge 510 moves in two degrees of freedom, with one degree of freedomcorresponding to the rod 512 moving into or out from sleeve 514. Therotation of rod 512 provides motion in the second degree of freedom.Screwing cap 520 sufficiently locks both degrees of freedom. Hinge 510can be incorporated into a shoulder orthosis such that motion of the rod512 into and out from sleeve 514 provides for movement of the patient'selbow toward or away from the torso while rotation of rod 514 providesfor movement of the arm toward the front or toward the rear.

In preferred embodiments, hinge 510 includes position sensors such thatthe orientation in each degree of freedom can be measured. In oneembodiment, rod 512 includes a resistive element 530 that can be used tocontact a conductive brush within sleeve 514. Resistive element 530 canbe used to measure the position of rod 512 as it projects to varyingdegrees within shaft 512. Similarly, rod 512 can further include aconductive brush 532 that contacts a resistive element. Brush 512 can beused to measure the orientation of rod 512 depending on the rotation ofrod 512 within sleeve 514.

A second multidimensional hinge 540 is displayed in FIG. 15. Hinge 540includes a first hinge 542 attached to a first lever arm 544. A secondlever arm 546 links first hinge 542 with second hinge 548. Rotationabout the first hinge involves relative rotational motion of first leverarm 544 relative to second lever arm 546 and second hinge 548. Thirdlever arm 550 is attached to second hinge 548, such that rotation aboutsecond hinge 548 rotates second lever arm 546 relative to third leverarm 550.

Preferably, first hinge 542 and second hinge 548 are separatelylockable, and, optionally, have adjustable resistance. Designs forsingle plane hinges described above can be used for first hinge 542 andsecond hinge 548. These hinges have position sensors, such that theorientation of each hinge can be measured. Multidimensional hinge 540can be used advantageously in orthoses for joints that move in multipleplanes. For example, hinge 540 can be used in a shoulder brace where oneof lever arms 544 and 550 moves with the patient's arm while the otheris fixed to their abdomen.

Strain gauges 114, 116, 142 can be useful for the performance of bothisometric and isotonic exercises. Strain gauges can be placed at anysuitable location such that the strain in the underlying materialreflects the torque applied between two respective flexibly connectedbody portions surrounding the joint of interest. Suitable locations forthe strain gauges involve placement of the strain gauges on a structurethat is attached to the corresponding hinge. The strain gauges generallyare located on a rigid element near the hinge that is under stress whentorque is applied to the hinge. Since different structures havedifferent relationships between the support portions and the hinge, thepreferred locations for the strain gauges depend on the particularconstruction of the orthosis.

Whether monitoring isometric exercises or isotonic exercises, strainmeasurements obtained by way of a strain gauge can be correlated withthe corresponding forces applied by the patient. Strain gauges 114, 116are connected to controller 112, which evaluates the strain based on theelectrical properties of the strain gauge. Suitable strain gauges areavailable from Vishay Micromeasurements Group (Raleigh, N.C.) (e.g.,type 125AD, part number EK-XX-125AD-350 with dual copper pads), or JPTechnologies (San Bernardino, Calif.). Evaluation of the strain isdiscussed further below in the context of controller 112.

As noted above, for a variety of treatments, it is useful to incorporatean instrumented hand hold. Referring to FIG. 16, a hand hold 600 ismounted on top of a support 602. Support 602 projects from a arm rest604. Support 602 should have a height for comfortable gripping of handhold 600. In preferred embodiments, arm rest 604 forms part of aninstrumented orthosis that, at least, extends past a patient's elbow.Arm rest 604 can be part of a shoulder brace, as described furtherbelow. Hand hold 600 can have any comfortable shape for gripping, suchas spherical or cylindrical.

As shown in FIG. 17, arm rest 604 can include a wrist hinge 606. Wristhinge 606 preferably includes a position sensor, a position lock andadjustable friction, as described above with respect to preferredembodiments of various hinge designs. Hand hold 600 rests on a handsupport 608 that connects to arm rest 604 through wrist hinge 606. Asshown in FIG. 17, hand hold 600 rests on hand support 608 withoutelevation with a support 602.

Hand hold 600 can be a bladder filled with a fluid, such as a gas,liquid or a pseudo-liquid formed by a granular material or the like.Alternatively, hand hold 600 can be formed from a compressible material,such as a foam or the like. The degree of compressibility can beselected to obtain a suitable amount of exercise from hand hold 600. Ifhand hold 600 is filled with a fluid, hand hold 600 can include one ormore valves 610. Valve 610 can be used to add or remove fluid from handhold 600 to vary the nominal pressure in ball 600.

Hand hold 600 preferably includes a pressure sensor 612 or a straingauge. Pressure sensor 612 can be used to measure the amount of forceapplied by a patient when squeezing hand hold 600. When hand hold 600 issqueezed, the pressure increases in hand hold 600, if hand hold 600contains a fluid. A strain gauge measures forces applied to squeeze ball600 according to the increased strain along the surface of ball 600.Pressure sensor 612 and/or a strain gauge generally are connected tocontroller 112 by wire 614.

Suitable strain gauges were described above. Pressure sensor 612 can beany reasonable type. A variety of suitable pressure sensors arecommercially available. Preferred pressure sensors include the MPXseries of pressure sensors manufactured by Motorola because of theirlinear output and small size, and NPP 301A from Lucas Novasensor,Fremont Calif., which are small and inexpensive. Other suitable pressuresensors use silver oxide ink surfaces separated by a dielectric materialor piezoelectric materials that produce a voltage when stressed.

In an alternative embodiment, the orthosis includes a hand grip 630, asshown in FIG. 18. Hand grip 630 can be mounted in the same way withrespect to an arm support 604 as squeeze ball 600. Hand grip 630includes finger rests 632. Finger rests 632 are indentations thatprovide a specific location for resting each finger. In preferredembodiments, hand grip 630 includes pressure sensors/strain gauges 634in the vicinity of each finger rest 632. Pressure sensors/strain gauges634 can be used to measure the force approximately corresponding to theforce applied by a particular finger. Pressure sensors/strain gauges 634are connected to controller 112 by way of wires 636.

Hand grip 630 generally includes some compartmentalization such thatforces applied by one finger are approximately segregated in effectwithin a corresponding compartment. Thus, if hand grip 630 includes afluid or fluids, the fluids can be placed within separate compartmentsfor each finger, preferably separated by a relatively rigid barrier.Similarly, a compressible material, e.g., a foam, supporting each fingercan be similarly separated by a relatively rigid barrier.

An instrumented orthosis can be configured to delivery one or moremonitored, therapeutic energy treatments along with the capability ofperforming monitored exercise. The therapeutic energy is delivered byway of an energy transducer. Suitable types of energy transducersinclude, for example, ultrasonic transducers, pulsed electromagneticfield transducers, implantable electrical current transducers, surfaceelectrical current transducers, and electrical muscle contractionstimulator. The transducers are located at an appropriate position toprovide treatment for the injured area. The transducers preferably arecontrolled and monitored by controller 112. Further discussion ofcombined treatment approaches using exercise and/or energy propagatingtransducers are described in published PCT application WO 96/36278,entitled “An Orthopedic Device Supporting Two or More Treatment Systemsand Associated Methods,” incorporated herein by reference.

In simplified embodiments, controller 112 may just include analogcircuits and a suitable display. In preferred embodiments, controller112 includes a digital processor to provide a more sophisticatedinterface with. the patient and/or with a health care professional, andto perform more involved monitoring functions. The digital processorpreferably is a microprocessor. The digital processor can be programmedin any of a variety of computer languages including, for example, basic,assembler, C, C++ and the like. Preferably, controller 232 is portable,which in this context means that the controller is small enough to beambulatory with the patient. More preferably, controller 112 is smallenough to be held in the hand of a patient, and even more preferably tobe placed in a standard shirt pocket.

A preferred microprocessor based controller 112 has several subsystemsincluding a power supply such as a battery, a transducer bias circuitsuch as described below, A/D converters, a microprocessor, real timeclock, RAM and non-volatile storage such as FLASH, SRAM or EEPROM, agraphic display such as a 64×128 pixel LCD display with a correspondingdriver, keypad, audible or tactile feedback device, data link totransducer, and an integral modem or RS232 standard output for serialconnection or modem access.

In one particular embodiment, the microprocessor is a MotorolaMC68HC11A1FN 8-bit microcontroller with built-in deep sleep shutdownmode for power conservation between active events, a programmable serialinterface and an 8-channel, 8-bit A/D converter. In this embodiment,controller 232 can provide analog multiplexing and A/D conversion for upto 8 analog input signals over a voltage range from 0.0 to +5.0 volts.For example, three of the channels can be devoted to provide signalconditioning for up to three strain gauges, and three of the channelscan be devoted to providing signal conditioning for up to three position(angle) sensors. The remaining two input channels then can be used foradditional treatment devices. If desired, added sensors can be handledby multiplexing and duty-cycling.

In this preferred embodiment, the controller module memory includesSRAM, FLASH and EEPROM, where each section is independently addressable.Each section can support, at least, 32K words with 8-bits (1 byte) perword. The EEPROM supports in-circuit reprogramming by way of themicrocontroller serial channel for code updates. The FLASH memoryprovides non-volatile storage of recorded data. The real time clock isbattery powered to allow time keeping to continue when themicrocontroller circuitry is off. The real time clock is capable ofgenerating periodic interrupts at a programmable rate to power switchingcircuitry to activate the microcontroller during an alert mode ofoperation.

The RS-232 interface consists of three conductor (TxD, RxD and GND) jacktype connector with a mechanical switch to automatically switch power onto all on-board electronics when the plug is inserted. The baud rate ofthe interface is programmable with standard rates such as 9600 and19200. A suitable display is a Densitron™ LE3328 LCD with HitachiHD61202 and HD61203 LCD controller chip sets. The display can be runwith a five volt supply that can be separate or not from the powersupply for the rest of controller 232. In this embodiment, a three keykeypad is interfaced with the microcontroller.

All of the components of controller 112 can be placed on the orthosis orin a separate case. The components of controller 112 can be integratedinto a single package or physically partitioned into portions mounted onthe orthosis frame and/or portions placed into one or more small cases.

Controller 112 preferably stores a software program that manages the useof the device for patient rehabilitation. The software can provide foralerting the patient to scheduled times for the performance of exercisesusing audible and/or vibratory signals. Controller 112 preferablyprovides instructions on the exercises as well as feedback andreinforcement messages to the patient. The software preferably is customprogrammed for the patient by a health care professional based on anevaluation of the patient's condition. Approaches for programming thecontrol unit is described further in the application No. 60/098,779.

Stored information relating to the patient's performance of exercisesgenerally is downloaded to the supervising health care professional atspecified intervals. The download of the information can be performed ina variety of ways. If the patient goes to the office of the health careprofessional, controller 112 can be directly connected to the monitorstation/computer using the RS232 port or other port using suitableprotocols including standard protocols. Alternatively, controller 112can be attached to a modem by way of the RS232 port or other suitableport. Since with certain embodiments the file sizes are relativelysmall, a single chip, 9 volt supply Rockwell® 2400 baud or 9600 baudmodem can be used. Controller 112 can be in radio communication with amonitor station. Controller 112 then would include a radio transmitterand, optionally, a receiver. Radio communication with a monitor stationis described further and U.S. Pat. No. 5,823,975 entitled “LocalMonitoring System For an Instrumented Orthopedic Restraining Device andMethods Therefore,” incorporated herein by reference. The display or atelevision set similarly can be in communication with controller 112 byway of radio transmissions or infrared communication such that a wireattachment is not necessary. Additional features of the controller aredescribe in the application No. 60/098,779.

In order for the value of electrical resistance associated with a straingauge to be useable as a measure of applied stress during isometricexercises, the values must be referenced to a “null” valve approximatelycorresponding to a value when no strain is applied to the orthosis. Thenull value can be set by a manual adjustment performed by the healthcare professional or by the patient. The “null” value, however, ispreferably established automatically without the need for calibration bythe user. Furthermore, the variations in the resistance due the straingauge preferably are converted into a voltage value that is amplified tomake efficient use of an analog-to-digital (A/D) converter with aspecified number of binary digits. A preferred summing amplifier circuitfor calibrated strain gauge measurement is described in detail in theapplication No. 60/098,779.

Further aspects of the improved orthoses are illustrated by reference tothree particular preferred embodiments.

A. Shoulder Brace

Referring to FIG. 19, a preferred embodiment of a shoulder brace 700includes trunk support 702, under arm support 704, upright support 706,shoulder hinge 708, arm support 710, elbow hinge 712, fore arm extension714 and controller 716. Trunk support 702 includes a padded hip rest 730contoured to rest comfortably against a patient's hip and distribute anydownward forces over a reasonable area. Padded hip rest 730 can includea relatively rigid shell, made from fiber glass, polytetrafluorethyleneother suitable polymers, metal or the like. Padding, such as clothcovered foam padding, can be placed adjacent the rigid shell. Trunksupport 702 generally further includes a strap 732, which can wraparound a patient's waist to secure trunk support 702. Strap 732preferably has an adjustable length, optional padding 734 and a fastenercomponent 736, such as a portion of a hook-and-loop fastener, a buckleor any other suitable fastener component. A second fastener component738 is attached to a strap or directly to padded hip rest 730, asdesired. Second fastener component 738 is the complement to fastenercomponent 736, such that fastener components 736, 738 can be secured toeach other.

Under arm support 704 includes a padded support portion 740, which caninclude a relatively rigid shell with padding located along the innerand/or upper surface. Under arm support 704 further includes a strap742, which can wrap around a patient's chest to secure under arm support704. Strap 742 has an optional pad 744, and preferably has an adjustablelength and a fastener component 746. A second fastener component 748 canbe attached to another strap or directly to padded support portion 748.Fastener components 746, 748 can be complementary components of a bucklefastener, a look-and-loop fastener, or any other suitable fastener.Under arm support 704 further includes a shoulder strap 750. Shoulderstrap 750 can include padding 752, and preferably has an adjustablelength. In this embodiment, shoulder strap 750 extends from strap 742 topadded support portion 740, although other configurations are possible.Shoulder strap 750 is designed to extend over the opposite shoulder ofthe patient relative to the shoulder supported by under arm support 704.

Upright support 706 connects padded hip rest 730, padded support portion740, and shoulder hinge 708. Upright support can be constructed from anyrigid material such as metal, fiber glass or other rigid material ormaterials. Upright support 706 can be bolted to padded hip rest 730 andpadded support portion 740, molded into a rigid shell of padded hip rest730 and padded support portion 740, or secured to padded hip rest 730and padded support portion 740 in any other reasonable fashion. Uprightsupport 706 can attach directly to a lever arm of shoulder hinge 708 orthrough a linking element connecting upright support 706 to a lever armof shoulder hinge 708. Upright support 706 holds padded hip rest 730,padded support portion 740 and shoulder hinge 708 at constant relativepositions.

Shoulder hinge 708 preferably is a hinge capable of motion in multipleplanes. Suitable designs for hinges with releasable motion in multipleplanes for use as shoulder hinge 708 are described above. As notedabove, upright support 706 is attached to one lever arm of shoulderhinge 708. A second lever arm of shoulder hinge 708 is attached to armsupport 710.

Aim support 710 preferably includes a support brace 760 and padded armsupport 762. Support brace 760 is attached to a lever arm of shouldhinge 708 and to a lever arm of elbow hinge 712, either directly orthrough a linker. Padded arm support 762 is connected to support brace760. Padded arm support helps the patient hold their arm in a properposition along support brace 760.

One lever arm of elbow hinge 712 is connected to support brace 760 and asecond lever arm of elbow hinge 712 is connected to fore arm extension714. Elbow hinge 712 is oriented such that rotation at the patient'selbow results in rotation of the hinge, if hinge 712 is in an unlockedsetting and the patient's arm is properly located along arm support 710and fore arm extension 714 with their hand gripping hand hold 774. Elbowpad 764 is attached to elbow hinge 712 or support brace 760. If desired,the lengths of arm support 710 and/or fore arm extension 714 can beadjustable.

Fore arm extension 714 includes extension shaft 770, bend 772 and handhold 774. Shaft 770 can be made adjustable, such that the distance fromthe elbow to the hand can be set to an appropriate value. Bend 772connects shaft 770 with hand hold 774. Hand hold 774 preferably is apadded grip. Bend 772 preferably is connected to shaft 770 by way of awrist hinge 776. Fore arm extension 714 preferably include straps 778 tosecure the patient's arm. The hinge shown in FIG. 9 can be adapted foruse as elbow hinge 712 and wrist hinge 776.

Shoulder brace 700 preferably includes a plurality of transducers. Asdepicted in FIG. 19, strain gauges 780, 782 are associated with uprightsupport 706 and support brace 760, respectively. Strain gauges 780, 782can supply measurements related to forces applied against a locked hingeor forces applied for rotation of shoulder hinge 708 and/or elbow hinge712. Shoulder hinge 708 preferably includes a multidimensional positionsensor 784, as described above. Elbow hinge 712 preferably includes aposition sensor, 786. Furthermore, hand hold 774 can include one or morepressure/stress transducers 788, to provide measurements related toforces applied by the patient's hand.

The transducers are preferably connected to controller 716, generally bywires, although transmitter based approaches can be used. Suitabledesigns for controller 716 were described above with respect tocontroller 112 of FIG. 1. Straightforward modifications can be made toaccommodate all of the transducers desired for shoulder brace 700.

To use shoulder orthosis 700, a patient can slip shoulder strap 750 overtheir arm and head. With the weight of shoulder brace supported onshoulder strap 750, straps 732 and 742 can be secured to distribute theweight and balance of shoulder brace 700 over the various supportsegments. With brace 700 secured to the patient's torso, the patient canposition their arm along arm support 710 with their appropriate handgripping hand hold 774. Shoulder brace 700 can serve as a support forthe patient's back, shoulder, elbow, wrist and/or hand. Furthermore,shoulder brace provides for a variety of exercises to assist with therecovery of an upper body injury, and/or to prevent the deteriorationfrom lack of use of joints near an injury. Potential exercise programsare described further below.

B. Lower Extremity Full Leg Brace

Referring to FIG. 20, a particular embodiment of a full leg brace 800includes waist support 802, hip hinge 804, thigh support 806, knee hinge808, shin support 810, ankle hinge 812, ankle/foot support 814, footrest 816 and controller 818. Waist support 802 preferably secures at thepatient's waist to support the upper portion of full leg brace 800.Waist support 802 can have a similar design as trunk support 702,described above. Waist support 802 generally includes support section820 and hinge link 822. Support section 820 can be formed from one ormore segments of rigid shell with inner padding to cushion contact withthe patient. Multiple rigid shell segments can be connected withflexible segments for easier fastening around the patient's waist. Waistsupport includes straps 824 or the like to provide for easy fasteningand unfastening of waist support 802. Hinge link 822 provides for rigidconnection of support section 820 with hip hinge 804.

Hip hinge 804 preferably is a hinge capable of motion in multipleplanes. Suitable instrumented hinges with motion in multiple planes weredescribed above. Preferred hip hinges 804 provide for motion of the legforward-to-back as well as side-to-side, when the hinge is unlocked.

Thigh support 806 includes a hinge link 830, a support segment 832 andframe members 834, 836. Hinge link 830 provides rigid support betweenhip hinge 804 and support segment 832. Support segment 832 preferablyencircles the patient's thigh, to secure thigh support 806. Supportsegment 832 generally includes rigid shell segments with padding. Inpreferred embodiments, support segment 832 includes flexible segmentsconnecting rigid shell segments. One or more flexible segmentspreferably include a releasable fastener 838, such as a hook-and-loopfastener to provide for easy fastening and unfastening of supportsegment 832. Frame members 834, 836 provide rigid connection betweensupport segment 832 and knee hinge 808. Frame members 834, 836 can bedesigned to have adjustable lengths to provide a proper fit.

In this embodiment, knee hinge 808 includes hinge elements 840, 842,connected, respectively, to frame members 834, 836. Several suitabledesigns for instrumented hinge elements 840, 842 are described above.Hinge elements 840, 842 connect to shin support 810, such that shinsupport 810 and thigh support 806 connect to different lever arms ofeach hinge element 840, 842.

Shin support 810 includes frame elements 850, 852 and straps 854, 856,858, 860 connected to frame element 850. Frame elements 850, 852 connectwith hinge elements 840, 842, respectively. The patient's leg restsbetween frame elements 850, 852. Straps 854, 856 connect over the frontof the patient's leg, while straps 858, 860 connect behind the patient'sleg. Straps 854, 856, 858, 860 can include padded portions. Straps 854,856, 858, 860 generally have an adjustable length and include fastenerelement 862, 864, 866, 868. Matched fastener elements 870, 872, 874, 876are connected to frame element 852 directly or with straps. Fastenerelements 870, 872, 874, 876 can be elements of a clip, a buckle,hook-and-loop fastener or other suitable fastener. Fastener elements870, 872 and 874, 876 together can be single sheets of hook or loopmaterial of a hook-and-loop fastener.

In this embodiment, ankle hinge 812 includes hinge elements 880, 882,connected respectively to frame elements 850, 852. Several suitabledesigns for instrumented hinge elements 880, 882 are described above.Hinge elements 880, 882 connect to ankle/foot support 814, such thatankle/foot support 814 and shin support 810 connect to different leverarms of each hinge element 880, 882.

Ankle/foot support 814 includes frame segments 884, 886. Frame segments884, 886 connect with hinge elements 880, 882, respectively. Framesegments 884, 886 further connect with foot rest 816. Frame segments canbe made adjustable such that the distance from hinge elements 880, 882to foot rest 816 can be adjusted to the proper length for the patient.

Foot rest 816 includes a heel support 890 and foot strap 892. Heelsupport 890 is contoured to the fit the rear portion of a patient'sfoot. Foot strap 892 wraps around the patient's foot to secure thepatient's foot against heel support 890. Strap 892 preferably has anadjustable length to obtain a proper fit. Foot strap 892 includes afastener portion 894 that connects with mated fastener portion 896.Fastener portion 896 generally is connected to heel support 890 on theopposite side relative to the connecting point of foot strap 892.Fastener portions 894, 896 can be portions of any suitable fastener,such as buckles, clasps, hook-and-loop fasteners and the like.

Full leg brace 800 preferably includes a plurality of transducers. Asdepicted in FIG. 20, strain gauge 900 is associated with hinge link 822.Strain gauge 902 is associated with frame member 834. Strain gauge 904is associated with frame segment 884. Strain gauges 900, 902 and 904 cansupply measurements related to forces applied against a locked hinge orrelated to rotation of hip hinge 804, knee hinge 808, and/or ankle hinge812. Hip hinge 804 preferably includes a multidimensional positionsensor 906, as described above. Hinge element 840 of knee hinge 808preferably includes a position sensor, 908, to measure the orientationof knee hinge 808. Similarly, hinge element 880 of ankle hinge 812preferably includes a position sensor, 910. Furthermore, heel support890 can include one or more pressure/stress transducers 898, to providemeasurements related to forces applied by the patient on their heel.

The transducers are preferably connected to controller 818, generally bywires, although transmitter based approaches can be used. Suitabledesigns for controller 818 were described above with respect tocontroller 112 of FIG. 1. Straightforward modifications can be made toaccommodate all of the transducers desired for full leg brace 800.

The brace shown in FIG. 20 is intended to be worn on the patient's leftleg. A corresponding brace can be constructed for the patient's rightleg based on this design by connecting the leg portion of the brace tothe other side of waste support section 820. The leg portion can beidentical in construction to the left leg version shown in FIG. 20, orthe leg portion can involve reversal of the left and right hand elementson the leg portion, such that the resulting right leg portioncorresponds to the left leg portion reflected through a symmetry planegoing through the center of the leg portion. Furthermore, a lowerextremity brace that supports both of the patient's legs can beconstructed with a single waste support section 820 connected throughtwo hip hinges 804 to appropriate supports for both legs.

For use, full leg brace 800 is placed around the patient's leg with thefoot supported by foot support 816, with waist support 802 secured atthe patient's waist, and support segment 832 secured around thepatient's thigh. Straps 854, 856, 858, 860 and 892 are appropriatelyfastened to fully support full leg brace 800. Full leg brace 800 can beused to provide valuable support for the patient as well as for theperformance of a variety of monitored, programmed exercises, asdescribed further below.

C. Stroke Brace

Preferred embodiments of a stroke brace have upper body and lowerextremity support. For the most common stroke debilitation, i.e.,hemiparesis affecting one whole side of the body, the shoulder brace andfull leg brace described above can be combined. Shoulder orthosis 700 ofFIG. 19 can be used along with lower extremities orthosis 800 of FIG.20. In these embodiments, a common trunk support is substituted fortrunk support 702 and waist support 802. The common trunk support isstraightforward to design by incorporating the features of trunk support702 and waist support 802.

With respect to instrumentation, transducers from orthoses 700, 800 canbe connected to separate controllers 716, 818, or the transducerspreferably can be connected to a single controller adapted toaccommodate all of the transducers of both orthoses. Shoulder orthosis700 can be physically connected to lower extremities orthosis 800 forstability, or orthoses 700, 800 can be physically disconnected exceptfor possibly connection to a single controller.

2. Rehabilitation Using Orthoses

The controllers described above preferably are programmed under thesupervision of an appropriate health care professional. In one preferredembodiment, the controller has four modes of operation: OFF, STANDBY,ALERT and FULL ON. In the OFF mode, primary and backup battery power areremoved, and no operations are taking place in the controller. In theSTANDBY mode, no primary battery power is online, and backup batterypower is used to maintain the real time clock and SRAM. Back-up powercan be supplied by a coin cell or the like. STANDBY mode is generallyused while the primary battery is being replaced or recharged.

In ALERT mode, the real time clock produces a signal at programmed,periodic intervals to activate all on-board electronic components.ALERT-ACTIVE submode has all circuits active. Exercises are generallyperformed during the ALERT-ACTIVE mode. In ALERT-SLEEP submode, only thereal time clock and SRAM memory remain active. ALERT-SLEEP mode is thestandard mode of operation between exercise prompts. To allow switchingbetween submodes, primary and backup battery power should be availableduring the ALERT mode. A beeper function can be used to prompt thepatient that an exercise time has been reached.

FULL-ON mode primarily is used during programming and data transferoperations. All on-board electronics and the display are active. FULL-ONmode can be activated automatically when an interface cable isconnected.

In a preferred embodiment, the controller can prompt and monitor theperformance of isometric exercises, range of motion exercises, isotonicexercises and/or neurosensory, reflex, proprioception and neuromotorexercises. When the patient has suffered a stroke, preferably theexercises involve more than simple proprioception. The stroke generallydestroys neurological pathways involving brain cells controllingreflexes, movements, and the like. Thus, the patient must relearn newneurological pathways connected to different memory locations. A varietyof reflex exercises can be used to relearn these neurological pathways.

When the health care professional programs the controller, the desiredexercises from this group of possible exercises are selected along withthe associated parameters and timing conditions for the selectedexercises. Also, the controller preferably can store two or more sets ofexercise routine parameters that can be used in different time intervalsrelative to the start of rehabilitation. In other words, after a firstset of exercise routines have been used for a certain period of time,the controller selects a second, generally more difficult, set ofexercises for the patient to perform. These exercises can be performedfor any selected joint or group of joints.

Similarly, the control unit can be programmed to prompt the patient toperform different exercises at different time of the day. These can bedesigned in a variety of ways by the health care professional based onthe particular circumstances of the patient. For example, the controlunit can prompt the patent to perform range-of-motion exercises everythree hours, finger squeeze exercises every hour and longer exercisesessions for neurological rehabilitation every evening.

Preferably, the controller prompts the patient at the time forperformance of the selected exercises. In some embodiments, the patientpresses a key when they are ready to proceed. The display on the monitorcan graphically show the patient's motions with suitable coordinates forthe particular exercise and compare them with a target performance, ifsuitable. The controller can store all of the data points or averagesover a set of exercises performed over a period of time.

To perform the isometric exercises of a particular joint, thecorresponding hinge is adjusted to a particular angle. If a manual hingeis used, the hinge is manually adjusted. The controller may instruct thepatient if the hinge is set at the desired angle. At the correct angle,the patient applies stress against the fixed hinge in one direction orthe other. The controller instructs the patient if the applied stressesare within tolerance values of a target value. The controller preferablyprompts the patient regarding the timing of the exercises, including therepetition rate and the amount of time to hold an applied stress. Afterthe selected number of repetitions are performed the exercises areterminated or a new angle of the hinge is selected. The process isrepeated until exercises are performed at all of the desired angles forthe particular joint. For hinges that rotate in multiple planes, thejoint can be exercised with forces applied along any plane of motionappropriate for the joint. The motion can be in a single plane at aparticular time or within multiple planes simultaneously, such as movinga hand in a circle with an outstretched arm.

Improvement in joint function can be advanced with attention toachieving a desirable range-of-motion (ROM). The ROM can be monitoredusing the orthosis with a suitable position sensing hinge or hinges, asdescribed above. The particular hinge is set to allow rotation, at leastover a portion of the possible rotation range. For hinges that rotate inmultiple planes of motion, the range-of-motion exercises can beperformed in the different planes.

Proprioception in this context refers to the patient's sense of positionin space, such as the bend of a particular joint. This seeming innateknowledge is a learned phenomenon involving a complex interaction ofnerve sensations from sensors that are processed and combined withfeedback and correction. A joint has dozens of single-celled measurementsensors: Paninian-like receptors, Ruffini corpuscles and the like. Thebrain and spinal cord process the information from these cellularsensors. When a joint is damaged, dozens of sensors may be permanentlylost. For example, the anterior cruciate ligament of a knee has over 60sensor/receptor cells some of which may be lost when the ligament tears.The body makes up for lost receptors by recruiting new sensorinformation from adjacent places. A new pathway and analysis must berelearned by the nervous system. With a properly designed orthosis thisprocess should be accelerated and enhanced.

In one embodiment, the controller display prompts an action through agraphic display, for example, to get a ball back into a circle, and thepatient must react quickly, reflexively with the rehabilitating joint inthe orthosis to move the ball on the screen. The position of the ball onthe screen is correlated with the position of the joint by way of theposition sensor in the orthosis operably connected to the controller. Bychanging the position of the joint, e.g. knee, the patient can move theball back into the circle or to another target of some kind. Theseexercises improve cooperation and coordination. A similar game formatcan be used to perform isometric exercises where the amount of strainmeasured by the strain gauge is used to move the cursor. Forhinges/joints that rotate in multiple planes, the full range of motioncan be explored in a proprioception exercise.

Isotonic exercises are similar to the range-of-motion exercises exceptthat selected resistance is provided in the selected hinge. Resistanceis provided by a manual unit, such as resistance unit 400 above, or byan electrical resistance hinge actuated by a controller, such aselectromechanical hinge 240 above. In any case, a desired amount ofresistance is set manually or automatically. The joint is then flexedover a prescribed range-of-motion. A controller can monitor the degreeof flexing of the joint using a position sensor in the hinge and theamount of forces applied during the flexing using a strain gauge. Thestrain gauge can be calibrated such that a strain reading can be matchedwith a corresponding torque applied to the hinge.

Some preferred embodiments include an additional component to providefor closed chain exercises when used with the joint supportingcomponent. Closed chain exercises involve muscular motion againstresistance to mimic natural motions against gravity or to providebalanced stresses to the joint. Closed chain exercises can be contrastedwith open chain exercises where a limb or trunk is moved or stressed inspace without any resistance against the motion other than perhaps theweight of the limb itself Closed chain exercise may provide morebalanced exercise of the various muscle groups within a patient's limbor trunk. The closed chain component may or may not be physicallyconnected with the joint supporting orthosis components.

For the performance of closed chain exercises, a body portion pushesagainst an essentially immovable surface. The surface can be a floor, awall, a table top or the like. In order to monitor the forces beingapplied, a sensor is used that is placed between the body part and thesurface, for example, the stress sensor 898 of heel support 890. Ifclosed chain exercises are to be performed with joints other than theknee, a suitable force sensor can be used. For example, a elbow can beexercised pushing with a hand against a pad sensor on a table or againsta wall. These sensors can be connected to the controller. Additionalinformation on the performance of the exercises described above and thecorresponding programming of the controller is found in the applicationNo. 60/098,779.

As noted above, the controller can be attached to a variety ofadditional devices, such as closed chain exercise units, energypropagating transducers and the like, to assist with treatment.Generally, the monitoring of the operation of these additional units canbe performed with the controller in a straightforward manner.

The controller can be programmed to accept other input from the patient.In particular, inquiries can be directed to the patient at the start ofan exercise routine, at the end of an exercise routine or at othertimes. The answers are stored for downloading to a health careprofessional along with suitable information regarding the performanceof programmed exercises.

As part of the monitoring operation, the controller preferably,continuously monitors the performance of an exercise to preventdifficulties. For example, after exercises have been started, thetransducer parameters are evaluated to determine if the exercises arebeing performed within specified parameters. If the exercises are notbeing performed within tolerance values, a sound warning can be given.Additional description on the performance of exercises with aninstrumented orthosis are described in the application No. 60/098,779.

Periodically, the information stored by the processor is downloaded to ahealth care professional. Various methods for downloading theinformation were described above. In principle, the controller can storeall of the information about the performance of particular sets ofexercise routines and download all of this information for analysis.Alternatively, the controller can perform some initial data analysis toreduce the amount of data that must be stored and transferred. Thepreliminary analysis, if any, performed by the controller can includegrouping and/or averaging of groups of exercises over certain periods oftime and/or performed at particular times of the day. Thus, raw oranalyzed data can be transferred. This analysis can involve anevaluation of variation with the progress of time to assist the healthcare professional evaluate whether the patient is making sufficientimprovement and to evaluate whether the exercise routine programmed intothe controller is appropriate.

To reduce the chance of the patient injuring themselves using theorthoses described herein, the patient preferably is examined by atrained health care professional prior to using the orthosis. Uponevaluating the condition of the patient, the controller is programmedfor suitable exercises. In preferred embodiments, a monitor stationassists the health care professional with the programming process. Oncethe controller is connected to the monitor station by way of an RS 232connection, a modem connection, a radio connection, a IR connection orother suitable connection using an appropriate protocol, the program isdownloaded into the controller.

At prescribed periods of time, information stored in the controllerregarding the performance of the exercises by the patient can bedownloaded into the monitor station. The time interval can be determinedbased on the storage capacity of the controller, the suitable length forevaluation of progress by health care professional or other similarissues. The download of information from the controller to the monitorstation can be performed at the health care facility where the monitorstation is located or from a remote location. If performed at the healthcare facility, the information can be downloaded by direct hook up ofthe controller with the monitor station or through a modem, radioconnection, infrared connection or the like. Remote hook up can beperformed with a modem connection, internet connection, radiocommunication or other longer range connection. A combination of thedownloading of performance parameters with telecommunications capabilityis described further in copending and commonly assigned U.S. patentapplication Ser. No. 09/226,866, entitled “REMOTE MONITORING OF ANINSTRUMENTED ORTHOSIS,” incorporated herein by reference.

Suitable analysis is performed of the data. for example, the downloadeddata on the exercises can be plotted in raw form or following some formof data averaging or selection. Based on an evaluation of the downloadeddata, the health care professional can maintain the exercise program inits initially programmed form or modify the exercise program to accountfor unexpected developments. In preferred embodiments, the health careprofessional can reprogram the controller remotely such that any desiredchanges in the routine can be made without the patient needing to visitthe health care facility. Further information on performance dataanalysis is found in the application No. 60/098,779.

One of several important functions of a microprocessor controlledorthosis is to monitor compliance with performance of exercises. Auseful adjunct to the compliance monitoring function can be achieved byperforming a psychological evaluation of the patient. The psychologicaltest can be used to evaluate the suitability of the programmed exercisesas well as indicate other potential problems with the healing processnot directly linked to the exercises.

Specifically, patients undergoing treatment for an injury are understress. Pain, immobility, lack of understanding, fear contribute to thestress resulting from the injury. The stress complicates recoverybecause the stress interacts with other emotional or physicalcomplaints. In particular, patients under stress undergo changes intheir psychology. This psychological change commonly manifests itself asdepression, fear, anxiety, anger or other types of decompensation.

The stress and associated changes in psychology complicates the recoveryby impairing the patient's ability to understand the problem and tocooperate fully in their own recovery. For example, depressed patientsexperience more pain, as measured by increased need for pain medication.Also, depressed patients exert less force during physical testing and,therefore, are measurably weaker. Thus, stress and associatedcomplications can result in an objective, measurable decrease inphysical ability.

In the past, such factors generally have been accommodated or acceptedas unavoidable because there has been no way to follow easily or toevaluate reasonably the changes in the patient's mental state. Theability to monitor the patient's mental emotional state can lead toimportant advances in the treatment of orthopedic injuries. To makeeffective use of the information on the patient's emotional state, theinformation preferably is coordinated with other aspects of theorthopedic and neurological recovery.

As a result of their injury, patients likely will undergo a predictableseries of changes as they first adapt to the pain of their injury, theinconvenience, the expense and the change in their function. Thepatient's emotional changes likely will include aspects of denial,anger, bargaining, acceptance, etc., which have also been associatedwith death and dying, as described by Elisabeth Kübler-Ross. For a morecomplete description of these emotional changes see “On Death andDying,” Elisabeth Kübler-Ross, Simon & Schuster (1969), incorporatedherein by reference. These changes can be correlated with predictable oridentifiable factors, such as age, gender, mechanism and socio-economicstatus.

The emotional changes are a form of psychological pain. Since it isknown that patients will undergo these emotional changes, a morecomplete treatment of the patient includes the management of theemotional changes accompanying the physical trauma. Effective managementand/or treatment of the emotional changes preferably would involve 1)education, 2) monitoring, 3) accurate characterization, 4)cooperation-based contingent intervention, and 5) communication.

In analogy with Kübler-Ross models, patients can benefit from the simpleknowledge that emotional changes are common and predictable. Reassuringinformation can be passed along to the patient at regular intervals,consistent with identifiable patient demographic parameters. Patientsuffering is reduced by mental preparation. The educational data canonly be presented with optimum timing if the patient's ability to absorbthe information is known. Thus, individual specific and time specificpsychological quantification can be used to considerable advantage.Psychological quantification can be accomplished efficiently throughportable psychological testing coordinated with the patient's physicaltherapy or exercise prescription. In particular, appropriate educationalinformation can be presented by the controller.

As part of the monitoring function, the treating professional preferablyknows what the patient is experiencing and when they are experiencingit. These experiences will be based on the patient's specific stresses,demands, events and individual psychology. The experiences also willparallel progress or relapse in the orthopedic treatment regime. Whilequalitative features of the patient's emotional responses may bepredictable, it is difficult to know when the psychological treatmentcan be effectively provided. By analogy, with physical discomfort thespecific timing of effective administration of pain medication,assistance with physical activities and nursing assistance is highlyvariable and patient specific. The treatment is more effective when thepatient is able to say when they require pain medication or other formsof help.

Monitoring is an important component to effective treatment. Effectivemonitoring is not possible without ongoing, systematic and injuryappropriate querying of the patient. To perform this in a cost effectiveway, the monitoring function must be portable with the patient. Thisportable monitoring can be accomplished by incorporating psychologicalmonitoring on an orthopedic management system, such as those describedherein. In particular, the monitoring function can be coordinated by thecontroller, which is programmed to pose questions and to receive answersfrom the patient. The psychological monitoring can be used to modifyparameters in the orthopedic management, such as device comfort,exertion levels and pain control, when the monitoring function detectsdeviations from an expected emotional or psychological condition.

To obtain an accurate characterization of the patient's emotional state,the treating professional and the patient need to work together todetermine the stage of the patient's emotional recovery, the depth andtype of the patient's distress, and changes in the patient's emotionalcondition as the problem either resolves or worsens. There are a numberof literature based instruments available that have been used tocharacterize patients on a one-time basis to quantify an emotionalstate. These instruments can be adapted to an ongoing monitoring of aconstantly evolving medical-surgical state, such as associated with anorthopedic or neurological injury.

A first instrument for emotional evaluation involves the formation of apain diagram. The patient is asked if the pain occurs at the expectedlocation. Pain away from the expected location may indicate acomplication or missed injury. See the discussion in Mayer et al., “AProspective Short-Term Study of Chronic Low Back Pain Patients UtilizingNovel Objective Functional Measurement, Pain 25:53-68 (1986),incorporated herein by reference.

An alternative approach is known as the Million analog scale. Thepatient is asked to characterize their discomfort based on a range ofpossible limitations. For example, they may be asked to state on anarbitrary scale their perceived functional restriction from “no pain” to“worst possible pain.” In addition, they may be asked whether they areeasily able to work, unable to work or some gradation between theselimits. The responses generally change based on the patient's recoveryprocess and their perception of their recovery process. Thus, this is astraightforward tool to regularly administer during high risk periods asa significant tool to report changes in the patient's condition. Forfurther discussion of this approach see, for example, R. Million et al.,“Assessment of the Progress of the Back-Pain Patient,” Spine,7(3):204-212 (1982), incorporated herein by reference.

Patient's often find it difficult to describe their symptoms. Inaddition, patients in a certain high risk category for back injury arelikely to have a range of educational limitations. This is a paradoxthat the patients who are most likely to sustain a certain type ofinjury are also least likely to be able to adequately characterize it asneeding and deserving treatment. The McGill Pain Questionnaire providesa tool to overcome these difficulties. The McGill Pain Questionnaireuses words that the patient can understand and appropriately choose, butwords that the patient would not likely use without suggestion. Thewords are provided in a format and grouping that tells more about thepatient's situation and emotional state than just their pain level. Afurther description of the McGill Pain Questionnaire is described in R.Melzack, “The McGill Pain Questionnaire: Major Properties and ScoringMethods,” Pain 1:277-299 (1975), incorporated herein by reference. Thequestionnaire can be updated and modified as appropriate.

Another potential instrument is the Beck Depression Inventory (BDI).Depression often follows injury and states of pain. A method of pollingthe patient for signs of depression would be another useful method ofcontrolling and improving the recovery process, as the patientprogresses through their disease process.

The BDI is a series of questions whose answers reflect the patient'smental state with respect to indications of depression. The BDI providesa standardized, objective measure that approximates clinical judgmentsof the intensity of depression without variability due to an evaluator'sidiosyncrasies or theoretical orientation. The BDI's ease ofadministration and low cost provide for its economical use, for example,with a patient suffering from an orthopedic injury. Furthermore,statistical analysis can be performed with the quantitative datagenerated by the BDI.

In its standard form, the BDI consists of 21 items that are scored toassess the patient's state of depression. Each of the 21 items can berated on a scale of 0-3 such that the total score ranges from 0-63. Thepatient selects the number next to a statement that reflects the waythat he/she has felt over a selected time period. The degree ofdepression is evaluated by the sum of the individual numbers with totalsindicating as follows: 0-9 no depression, 10-16 mild depression, 17-29moderate depression and 30-63 severe depression. In the standard test,the 21 items are: 1) sadness, 2) pessimism, 3) failure, 4)dissatisfaction, 5) guilt, 6) punishment, 7) self-dislike, 8)self-accusations, 9) suicidal thought, 10) crying, 11) irritability, 12)withdrawal, 13) indecision, 14) self-image, 15) work inhibition, 16)insomnia, 17) fatigue, 18) anorexia, 19) weight loss, 20) hypochondria,21) libido loss.

In summary, these instruments can be used 1) to demonstrate the locationof pain as typical or atypical (the pain diagram), 2) to evaluate thepatient's own perceived level of disability (the million analog scale),3) to describe the specific nature of the pain as stinging, burning,torturing, or the like (the McGill Pain Questionnaire), or to reflectthe effect of the difficulties on the patient's mental state (BeckDepression Inventory). Suitable tests are described further in theapplication No. 60/098,779. Thus, standardized instruments for emotionalevaluation can be integrated into an orthopedic treatments regimeorganized around an instrumented orthosis.

In particular, the questions can be posed and the answers receivedthrough the controller. These questions can be posed at regularintervals. The questions can be interspersed throughout the day andcoordinated with the timing of exercise routines. In particular,different subset of questions can be asked at different times. Forexample, a subset of questions on pain levels can be asked in themorning while a subset of questions on depression can be asked in theafternoon. To assist with these tests, the controller can be attached toa television set to provide a larger display, if desired. Ifadministered in an appropriate and timely manner, the subjective aspectsof the patient's suffering can be identified and quantified forappropriate intervention.

The psychological test can be integrated with the physical evaluation ofthe patient to form a more complete overall evaluation. Using thisevaluation, the exercise routine can be modified in response partly tothe to mental attitude of the patient to help assure further compliancewith the exercises and to increase the comfort level of the patient. Thebalance of all of these factors can lead to faster rehabilitation of thepatient.

The patient's ability to cooperate with their treatment is determined bytheir emotional state. Like physical pain, the patient's emotional statechanges in a highly individualized manner. If the patient's emotionalstate can be more scientifically evaluated, characterized and bracketedwith identifiable ranges and types, the modification to a more effectiveor more pleasurable reinforcement scheme can be assisted throughcooperation-based contingent intervention. In particular, theinformation received from the patient is used to improve the cooperationof the patient in their own recovery. Thus, the relationship between thepatient and the treating professional is augmented in a way thatstrengthens the relationship without adding unreasonable cost totreatment.

With respect to implementing the cooperation-based contingentintervention, the controller first evaluates the immediacy of thepatient's state. If there are serious concerns, such as if the patientindicates that the pain is unbearable or tortuous or if the patient isseriously depressed, the controller can either instruct the patient toimmediately call the doctor or directly interface with the healthprofessional's computer to down load the information, with the patient'shelp, if needed. Alternatively, the controller can modify the exerciselevel by decreasing the exertion if the pain is higher than desired orincrease the level if the pain is low and the patient is frustrated bythe slow pace.

Thus, the patient's physical and mental condition, as communicated inthe psychological evaluation, can provide useful information regardingthe modifications to the treatment program in response to the patient'sevolving physical condition and the mental state of the patient.Cooperation-based contingent intervention involves integrating theresult of the psychological evaluation to the patient's evolvingphysical abilities to provide for improved adjustment of the treatmentprogram. For example, a variety of different formats for presenting aparticular exercise can be tried to evaluate whether the patient is morereceptive to the particular formats. The formats can be put in the formof a game or in the form of detailed instructions with continuouspositive reinforcement.

Communication with the health care professional is an important aspectof the process. The controller can be used to intervene in thecommunication process to ensure that important information iscommunicated in a timely way. Regardless of any immediate concerns, theoutcome of the patient's responses are reported to the treatingprofessional for confirmation, data analysis and other types of support.Prior to evaluation by the health care professional, the patient'sresponses are characterized and identified. This can be done by thecontroller or by a remote processor. A scientific and quantifiablemethod of evaluating emotional change is an important component of theevaluation process.

As a supplement to or as an alternative to, the questioning of thepatient regarding their emotional state, physiological measurements canbe made regarding conditions correlated with stress. For example, pulserate can be measured with, for example, a laser Doppler sensor or apulse oximeter. A pulse oximeter is an apparatus that the patientinserts their finger into to measure pulse rate and blood oxygenation.Similarly, galvanic skin response can be measured using electrodesplaced on the skin. The electric resistance of skin is measured with theelectrodes. In addition, blood pressure can be measured with a bloodpressure cuff These physiological measurements can be controlled andmonitored with the controller. The physiological measurements can thenbe downloaded to the health care provider.

The embodiments described above are intended to be illustrative and notlimiting. Additional embodiments are within the claims. Although thepresent invention has been described with reference to preferredembodiments, workers skilled in the art will recognize that changes maybe made in form and detail without departing from the spirit and scopeof the invention.

What is claimed is:
 1. A medical device comprising: a display, an inputdevice, a memory device, and a processor communicatively coupled to thedisplay, the memory, and the input device, the memory includinginstructions, which when executed by the processor, cause the processorto: present an orthopedic treatment program regime to a user via thedisplay; present questions, using the display, for evaluating apsychological state of the user via the display, wherein thepsychological state of the user includes the user's own perceived levelof disability; receive answers to the questions from the user via theinput device; determine, using the processor, the psychological state ofthe user; and based upon the determination of the psychological state ofthe user, modify the orthopedic treatment regime using the processor. 2.The medical device of claim 1 wherein the processor has analog todigital multiplexing capability.
 3. The medical device of claim 1,comprising an output interface.
 4. The medical device of claim 3,wherein the memory includes instructions which cause the processor to:evaluate emotional change of the user; and send the evaluation of theemotional change to a health care provider via the output interface. 5.The medical device of claim 3, wherein the output interface is one of:an RS232 port and a radio transmitter.
 6. The medical device of claim 1,wherein the questions relate to depression.
 7. The medical device ofclaim 6, wherein determining the psychological state of the usercomprises performing a statistical analysis on the answers to obtain anobjective quantitative measure of depression.
 8. The medical device ofclaim 1, wherein the memory further includes instructions which causethe processor to: receive an indication of the position of one or morejoints of the user from a physiological sensor connected to an orthosis;calculate compliance information indicative of the user's compliancewith the orthopedic treatment regime; and store the complianceinformation in the memory.
 9. The medical device of claim 1, wherein thedevice is further connected to electrodes configured to measure agalvanic skin response.
 10. The medical device of claim 1, having a sizesuch that it can be held in the hand of a patient.
 11. The medicaldevice of claim 1, wherein the memory further includes instructionswhich cause the processor to: determine that the psychological state ofthe user is severely depressed based upon the answers; and display amessage to the patient to seek help via the display.
 12. The medicaldevice of claim 1, wherein the orthopedic treatment regime is modifiedby increasing the pace of the treatment regime.
 13. The medical deviceof claim 1, wherein the orthopedic treatment regime is modified bychanging a format of at least one exercise included in the treatmentregime.
 14. The medical device of claim 1, wherein the memory furtherincludes instructions which cause the processor to: determine that thepsychological state of the user is severely depressed based upon theanswers; and send information indicating that the user is severelydepressed to a health professional's computer terminal via an outputinterface.
 15. A method for monitoring a patient undergoing a treatmentplan, the method comprising: presenting an orthopedic treatment regimeto a user on a display; presenting questions for evaluating apsychological state of the user on the display, wherein thepsychological state of the user includes the user's own perceived levelof disability; receiving answers to the questions via an input device;using a computer processor to perform the operations of: determining thepsychological state of the user including the user's perceived level ofdisability; and based upon the determination of the psychological stateof the user, modifying, using the processor, the orthopedic treatmentprogram regime.
 16. The method of claim 15, wherein the questions relateto depression.
 17. The method of claim 16, wherein determining apsychological state of the user comprises performing a statisticalanalysis on the answers to obtain an objective quantitative measure ofdepression.
 18. The method of claim 15, comprising receivingphysiological measurements indicating the position of one or more jointsof the user from a physiological sensor connected to an orthosis;calculating compliance information indicative of the user's compliancewith the orthopedic treatment regime; and storing the complianceinformation in a memory, the memory communicatively coupled to theprocessor.
 19. The method of claim 15, comprising: determining that thepsychological state of the user is severely depressed based upon theanswers; and sending information indicating that the user is severelydepressed to a health professional's computer terminal via an outputinterface.
 20. The method of claim 15, comprising: determine that thepsychological state of the user is severely depressed based upon theanswers; and display a message to the user to seek help via the display.21. The method of claim 15, wherein the orthopedic treatment regime ismodified by increasing the pace of the treatment regime.
 22. The methodof claim 15, wherein the orthopedic treatment regime is modified bychanging a format of at least one exercise included in the treatmentregime.
 23. The method of claim 15, comprising: evaluating emotionalchange of the user; and sending the evaluation of the emotional changeto a health care provider via the output interface.